FDA 510(k) Application Details - K012688

Device Classification Name	Catheter, Recording, Electrode, Reprocessed   More FDA Info for this Device
510(K) Number	K012688
Device Name	Catheter, Recording, Electrode, Reprocessed
Applicant	VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. LAKELAND, FL 33815 US Other 510(k) Applications for this Company
Contact	MIKE SAMMON Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	NLH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2001
Decision Date	07/31/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review